SUMMARY  

• THOR (BLC3001/NCT03390504) is an ongoing, phase 3, open-label, multicenter study evaluating the efficacy and safety of BALVERSA vs chemotherapy (docetaxel or vinflunine) or pembrolizumab in patients with metastatic or unresectable urothelial carcinoma (UC) and selected fibroblast growth factor receptor (FGFR) gene alterations that has progressed during or after 1 or 2 prior lines of therapy.^1,2
  • Patients enrolled in the study were required to have adequate hepatic function described as: total bilirubin ≤1.5x institutional upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5x institutional ULN.³ 
  • Patients with known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection were excluded. Patients with a history of hepatitis C infection but polymerase chain reaction (PCR)-negative and those with hepatitis B with postive hepatitis B surface antibody were eligible.³ 
• BLC2001 (NCT02365597) is a phase 2, multicenter, open-label study in adult patients with locally advanced and unresectable or metastatic UC and prespecified FGFR genetic alterations (FGFR3 mutation or FGFR2/3 fusion) with disease progression during or following ≥1 line of prior systemic chemotherapy or within 12 months of receiving neoadjuvant or adjuvant chemotherapy, or were chemotherapy-naïve due to cisplatin ineligibility. Efficacy and safety results are described for patients who received a starting dose of BALVERSA 8 mg orally once daily (N=99).^4,5
  • Patients enrolled in the study were required to have adequate hepatic function described as: total bilirubin ≤1.5x institutional ULN, unless known to have Gilbert’s disease; ALT and AST ≤2.5x institutional ULN; and albumin ≥2.0 g/dL.⁶
  • Exclusion criteria included known HIV infection, or active hepatitis B or C infection. Patients with a history of hepatitis C infection but negative hepatitis C virus PCR test and patients with hepatitis B with positive hepatitis B surface antibody were allowed.⁶
• No clinically meaningful differences in the pharmacokinetics (PK) of erdafitinib were observed with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and patients with normal hepatic function based on PK analysis. No dose adjustment is required for patients with mild or moderate hepatic impairment based on population PK analyses.⁷
• A population PK model was developed using data pooled from 6 clinical studies (3 in healthy volunteers and 3 in patients with cancer) to characterize total and free plasma concentrations of erdafitinib following single- and multiple-dose administration, to quantify the inter- and intraindividual variability in erdafitinib PK, and to understand clinically relevant covariates (N=373). The analysis demonstrated that mild hepatic impairment was not a significant covariate of erdafitinib exposure.⁸
• Limited data are available in patients with severe hepatic impairment.⁷

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 10 February 2025.